FDA.reportPublic FDA data

simvastatin

Product NDC
71610-050
11-digit product format
716100050
Labeler code
71610
Product ID
71610-050_79661dad-20cb-47b6-a8b8-7f946189f9b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078155
Marketing category
ANDA
Marketing start
2008-02-26
Substance
SIMVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV
Rxcui198211

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-050-302021-04-27C16284748780-19d75b9d0-2470-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
71610-050-452021-04-27C16284748780-19d75b9d0-2470-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
71610-050-302020-01-31C16284748780-19d75b9d0-2470-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991
71610-050-452020-01-31C16284748780-19d75b9d0-2470-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use simvastatin tablets safely and effectively. See full prescribing information for simvastatin tablets. SIMVASTATIN Tablets USP for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-050-30simvastatin30 in 1 BOTTLETABLET, FILM COATED302
71610-050-45simvastatin45 in 1 BOTTLETABLET, FILM COATED452
71610-050-60simvastatin90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-050-30EA - Each71610-0505481c978-d97b-4284-9698-e51159e864f312018-07-03
71610-050-45EA - Each71610-050e0e91515-8ee0-442a-96ec-e0f746486dfc12018-07-03
71610-050-60EA - Each71610-050465fa6d4-0c68-488c-b8ad-8a10668e6dec12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-050SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 3 package rows20210428_b5bebcd0-84e6-410d-af96-63834d262bad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198211simvastatin 40 MG Oral TabletPSNb5bebcd0-84e6-410d-af96-63834d262bad2
198211simvastatin 40 MG Oral TabletSCDb5bebcd0-84e6-410d-af96-63834d262bad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-050-307161000503030 TABLET, FILM COATED in 1 BOTTLE (71610-050-30) 2018-04-160000-00-00NoNoCurrent
71610-050-457161000504545 TABLET, FILM COATED in 1 BOTTLE (71610-050-45) 2018-04-160000-00-00NoNoCurrent
71610-050-607161000506090 TABLET, FILM COATED in 1 BOTTLE (71610-050-60) 2021-03-090000-00-00NoNoCurrent